Label: MOISTURIZING HAND- benzalkonium chloride lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 18, 2011

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  • ACTIVE INGREDIENT

    BENZALKONIUM CHLORIDE 0.1 PERCENT

  • PURPOSE

    ANTIMICROBIAL

  • USES

    TO HELP REDUCE BACTERIA ON THE SKIN. RECOMMENDED FOR ROUTINE USE.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES.  IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

    STOP USING THIS PRODUCT AND ASK DOCTOR IF

    IRRITATION OR REDNESS DEVELOPS AND LASTS.

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DIRECTIONS

    APPLY A SMALL AMOUNT TO PALM AND RUB HANDS TOGETHER THOROUGHLY.

  • INACTIVE INGREDIENTS

    WATER, CYCLOPENTASILOXANE, GLYCINE SOJA (SOYBEAN) OIL, GLYCERIN, CETEARYL ALCOHOL, CETEARETH-20, GLYCERYL STEARATE, DIMETHICONE, CETYL ALCOHOL, STEARYL ALCOHOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, ETHYLHEXYL PALMITATE, DICAPRYLYL CARBONATE, THEOBROMA CACAO (COCOA) SEED BUTTER, FRAGRANCE, COCOS NUCIFERA (COCONUT) FRUIT EXTRACT, CITRUS MEDICA LIMONUM (LEMON) EXTRACT,  ETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, PPG-26-BUTETH-26, PEG-40 HYDROGENATED CASTOR OIL,  DMDM HYDANTOIN, MANNITOL, CELLULOSE, TOCOPHERYL ACETATE, HYDROXYPROPYL METHYLCELLULOSE, CHROMIUM HYDROXIDE GREEN (CI 77289), YELLOW 5 (CI 19140), YELLOW 10 (CI 47005).

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF MOISTURIZING HAND LOTION

  • INGREDIENTS AND APPEARANCE
    MOISTURIZING HAND   CITRUS COCONUT
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-331
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    COCONUT (UNII: 3RT3536DHY)  
    LEMON (UNII: 24RS0A988O)  
    OCTINOXATE (UNII: 4Y5P7MUD51)  
    AVOBENZONE (UNII: G63QQF2NOX)  
    OCTISALATE (UNII: 4X49Y0596W)  
    POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    MANNITOL (UNII: 3OWL53L36A)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CHROMIC OXIDE (UNII: X5Z09SU859)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-331-0372 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/18/2011
    Labeler - CVS PHARMACY (062312574)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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